BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 816159 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-18946
    Event Type
    Injury
    Date Received
    February 8, 2007
    Date of Event
    October 16, 2006
    Report Date
    October 16, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1107-9/05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED AN END OF LIFE (EOL) INDICATOR WITH A MONITORIN VOLTAGE OF 2.67 AND A CHARGE TIME OF 34.8 SECONDS. THIS DEVICE IS PART OF THE AVT LATCHING POPULATION (6/17/2005).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE ATRIAL GENERATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention